Stents are widely used for supporting a lumen structure in a patient's body. For example, stents may be used to maintain patency of a coronary artery, carotid artery, cerebral artery, popliteal artery, iliac artery, femoral artery, tibial artery, other blood vessels including veins, or other body lumens such as the ureter, urethra, bronchus, esophagus, or other passage.
Stents are commonly metallic tubular structures made from stainless steel, Nitinol, Elgiloy, cobalt chrome alloys, tantalum, and other metals, although polymer stents are known. Stents can be permanent enduring implants, or can be bioabsorbable at least in part. Bioabsorbable stents can be polymeric, bio-polymeric, ceramic, bio-ceramic, or metallic, and may elute over time substances such as drugs. Non-bioabsorbable stents may also release drugs over time. Stents are passed through a body lumen in a collapsed state. At the point of an obstruction or other deployment site in the body lumen, the stent is expanded to an expanded diameter to support the lumen at the deployment site.
In certain designs, stents are open-celled or close-celled cylindrical structures that are expanded by inflatable balloons at the deployment site. This type of stent is often referred to as a “balloon expandable” stent. Stent delivery systems for balloon expandable stents are typically comprised of an inflatable balloon mounted on a multi lumen tube. The stent delivery system with stent crimped thereon can be advanced to a treatment site over a guidewire, and the balloon inflated to expand and deploy the stent.
Other stents are so-called “self expanding” stents and do not use balloons to cause the expansion of the stent. An example of a self-expanding stent is a tube (e.g., a coil tube, a mesh tube, or an open-celled tube) made of an elastically deformable material (e.g., a superelastic material such a nitinol). This type of stent is secured to a stent delivery device under tension in a collapsed state. At the deployment site, the stent is released so that internal tension within the stent causes the stent to self-expand to its enlarged diameter.
Other self-expanding stents are made of so-called shape-memory metals. Such shape-memory stents experience a phase change at the elevated temperature of the human body. The phase change results in expansion from a collapsed state to an enlarged state.
A very popular type of self expanding stent is an open-celled tube made from superelastic nitinol, for example, the Protégé GPS stent from ev3, Inc. of Plymouth, Minn. Open or closed cell tube stents are commonly made by laser cutting of tubes, or cutting patterns into sheets followed by or preceded by welding the sheet into a tube shape, and other methods. Another delivery technique for a self expanding stent is to mount the collapsed stent on a distal end of a stent delivery system. Such a system can be comprised of an outer tubular member and an inner tubular member. The inner and outer tubular members are axially slideable relative to one another. The stent (in the collapsed state) is mounted surrounding the inner tubular member at its distal end. The outer tubular member (also called the outer sheath) surrounds the stent at the distal end.
Prior to advancing the stent delivery system through the body lumen, a guide wire is first passed through the body lumen to the deployment site. The inner tube of the delivery system is hollow throughout at least a portion of its length such that it can be advanced over the guide wire to the deployment site. The combined structure (i.e., stent mounted on stent delivery system) is passed through the patient's lumen until the distal end of the delivery system arrives at the deployment site within the body lumen. The deployment system and/or the stent may include radiopaque markers to permit a physician to visualize positioning of the stent under fluoroscopy prior to deployment. At the deployment site, the outer sheath is retracted to expose the stent. The exposed stent is free to self-expand within the body lumen. Following expansion of the stent, the inner tube is free to pass through the stent such that the delivery system can be removed through the body lumen leaving the stent in place at the deployment site.
In prior art devices, the stent may prematurely deploy as the outer tube is retracted accidentally. Further, once the stent has been deployed, subsequent adjustment of the stent deployment location can be difficult because re-sheathing typically cannot be readily accomplished. To overcome some of these problems some stent delivery systems are comprised of interlocks on the stent and on the inner member. See for example U.S. Pat. No. 6,814,746 to Thompson et. al., entitled “Implant Delivery System With Marker Interlock”, and U.S. Pat. No. 6,623,518 to Thompson et. al., entitled “Implant Delivery System With Interlock”, the contents of both included herein in their entirety by reference.
A common problem with stents properly deployed in some vessels is that the stents fracture over time. Problems secondary to stent fracture can include pain, bleeding, vessel occlusion, vessel perforation, high restenosis rate, non-uniform drug delivery profile, non-even vessel coverage and other problems, and re-intervention may be required to resolve the problems. Stents are commonly designed for high pulsatile fatigue life, i.e., for resistance to fracture under the diametrical pulsatile movement in an otherwise static blood vessel, as may be appropriate for some implantation sites. Stents however are not usually designed for resistance to fracture under in-patient loading conditions other than pulsatile, as is appropriate for other implantation sites. Stents at implantation sites such as the popliteal artery, iliac artery, femoral artery, tibial artery, and others can suffer from large amounts of axial, bending, or torsional cyclic loading and from large amounts of bending and twisting. It is believed that the high fracture rate of stents implanted in these locations is due to stent designs and stent material mechanical properties that are incapable of withstanding the high mechanical forces applied to the stents by patient activity over and above those forces produced by the beating heart.
Attempts have been made to improve the fatigue resistance of materials used for implantable medical devices. In U.S. Pat. No. 6,780,261 Trozera proposes use of malleable, recrystallized materials. This approach is unlikely to be suitable for many self expanding stent applications where malleability should be low. In Wu (U.S. Patent Application Publication Number 2004/0241037), Dooley (U.S. Patent Application Publication Number 2004/0216814), and Patel (U.S. Patent Application Publication Number 2005/0090844) the use of cold working or pre-straining is disclosed, and in Walak (U.S. Patent Application Publication Number 2005/0059994) use of a stabilized martensitic surface is disclosed. However, one cannot always uniformly apply these approaches to the surface of an implant because of limiting factors such as access and geometry.
What is needed is a stent that can be easily manufactured and that will survive without fracture when implanted in locations that experience high mechanical forces produced by patient activity over and above those forces produced by the beating heart.